droplet® pen needles 31G x 5mmRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05907996093069), received between Mar 26, 2018 and Mar 17, 2023 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (13 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2023Failure to Prime; Infusion or Flow Problem; No Flow; Failure to Prime; Infusion or Flow Problem; No Flow

  "PATIENT RECEIVED 4 TOTAL BOXES OF DROPLET PEN NEEDLES, 31G X 5MM WITH LOT NUMBER: B56Y7. PATIENT RECEIVED 2 BOXES INITIALLY, EXPERIENCED PROBLEMS, RECEIVED AN ADDITIONAL 2 BOXES, AND CONTINUED TO EXPERIENCE PROBLEMS. PATIENT IS NEW TO THE DROPLET BRAND, AND SHE HAS BEEN USING (OTHER BRAND) NEEDLES FOR ABOUT 25 YEARS. SHE HAS NEVER EXPERIENCED THIS PROBLEM BEFORE. PATIENT CLAIMS THAT MANY OF THE PEN NEEDLES WOULD NOT PRIME. SHE WOULD ATTEMPT TO PRIME THE PEN NEEDLES 3-5 TIMES BEFORE THE INSULIN PEN FORCEFULLY EJECTED A LARGER AMOUNT OF INSULIN THAN WAS LAST DIALED: AS THOUGH THE PEN WAS BACKED UP AND THEN SHOT OUT ALL THE INSULIN THAT WAS BACKED-UP AT ONCE. PATIENT WOULD THEN CHANGE THE PEN NEEDLE AND TRY A DIFFERENT ONE. PATIENT ALSO REPORTED THAT, AFTER SOME OF HER INJECTIONS, HER BLOOD SUGAR REMAINED HIGH. SHE CLAIMS THAT SHE WOULD BE "UP ALL NIGHT" ATTEMPTING TO INJECT INSULIN TO CORRECT HER SUGAR WITH NO SUCCESS. PATIENT EVENTUALLY SWITCHED BACK TO (OTHER BRAND) NEEDLES AND HAS NOT EXPERIENCED ANY PROBLEMS SINCE. PATIENT DID NOT SEEK OUT OR RECEIVE MEDICAL ATTENTION AS A RESULT OF HER HIGH BLOOD SUGAR. SHE REPORTS NO OTHER ADVERSE HEALTH EFFECTS OTHER THAN HIGH BLOOD SUGAR AND

  Patient problems: Discomfort; Hyperglycemia

  MAUDE report 16563406 ↗
• MalfunctionJun 24, 2022Break; Detachment of Device or Device Component; Material Twisted/Bent; Break; Detachment of Device or Device Component; Material Twisted/Bent

  ON (B)(6) 2022, THE NEEDLE BROKE OFF IN PATEINTS ABDOMEN, MY HUSBAND NEEDED A FLASH LIGHT AND TWEEZERS TO REMOVED IT. I OPEN ONE DAYS AGO AND THE NEEDLE WAS ALREADY BENT. THESE NEEDLES ARE SHORT AND TINY, I DID NOT KNOW I WOULD BE TAKING A RISK CAUSING HARM FROM THEM BREAKING OFF IN MY BODY AND/ OR BENDING. THIS IS NOT THE FIRST TIME SHE HAS BEEN INJURED BY OUR PRODUCT. SHE HAS USED THE PRODUCT FOR YEARS WITHOUT INCIDENT BUT WITH THIS LOT NO. SHE HAS EXPERIENCED THE NEEDLE BREAK AS DESCRIBED ABOVE, A NEEDLE STICK DUE TO THE PN BEING BENT ON THE PATIENT END AND BEING EXPOSED THROUGH THE CAP, AND RECENTLY SHE EXPERIENCED THE PN BENDING INTO HER ABDOMEN BUT, NOT ACTUALLY BREAKING OFF.WITH THE PN STICK THAT DID BREAK OFF, THERE WAS NO BLOOD AND HUSBAND WAS ABLE TO FULLY REMOVE IT SO MEDICAL ATTN.

  Patient problems: Needle Stick/Puncture

  MAUDE report 14797831 ↗
• MalfunctionApr 6, 2020Infusion or Flow Problem; Infusion or Flow Problem

  THE PATIENT RECEIVED 4 BOXES OF DROPLET 31G X 8MM WITH LOT NO. Y56F8. HE USES FLEX PEN TO INJECT 4X PER DAY. USER CALLED IN STATING THAT THE PN DON'T WORK. HE STATES THAT NO INSULIN COMES OUT THE PN AS IF THEY'RE CLOGGED. HE DOESN'T REUSE PN.

  Patient problems: Missing Value Reason

  MAUDE report 9928215 ↗
• MalfunctionMar 6, 2020Infusion or Flow Problem; Infusion or Flow Problem

  USER RECEIVED 1 BOX OF DROPLET 31G X 5MM PM FROM HUMANA WITH LOT NO. Z58P1. HE INJECTS 35 UNITS OF LANTUS 1X PER DAY. HE EMAILED STATING THAT, "1 IN 3 WILL NOT WORK. NOTHING WILL COME OUT OF THEM. USER CLAIMS THAT HE IS LOSING LANTUS SOLO START AND NEEDLES TOO. USER IS INJECTING CORRECTLY AND HE DOES NOT REUSE NEEDLES BASED ON COLLECTED INFORMATION FROM USER.

  Patient problems: No Information

  MAUDE report 9797345 ↗
• MalfunctionJun 6, 2019Material Twisted/Bent; Material Twisted/Bent

  RECENTLY, SEVERAL PATIENTS USING THE DROPLET PEN NEEDLES HAVE EXPERIENCED THE PEN NEEDLES BREAKING OFF IN THEIR ARMS AND BENDING WITH EACH USE.

  Patient problems: No Information

  MAUDE report 8673182 ↗
• MalfunctionMay 16, 2019Material Twisted/Bent; Material Twisted/Bent

  MR. (B)(6) CALLED TO ADVISE THAT THE NEEDLES ARE BENDING. HE SAYS THE BEND IS WHERE THE NEEDLE MEETS THE PLASTIC AT THE TOP OF THE PEN NEEDLE. ALSO, HE HEARS A POPPING WHEN THEY PIERCE THE SKIN. THEY AREN'T PAINFUL, BUT DO MAKE NOISE. HE IS CONCERNED THAT WITH THE BEND IN THE NEEDLE HE ISN'T GETTING HIS FULL DOSE OF INSULIN. HE DOSES 4X'S A DAY AND USES NOVOLOG AND LANTUS. HE HAS NOTICED THAT THE NEEDLE BENDS WITH BOTH OF THIS PENS. HE WILL RETAIN ANY THAT BEND MOVING FORWARD UNTIL HIS REPLACEMENT PRODUCT ARRIVES. HOWEVER, HE HAS DISPOSED OF THE NEEDLES ALREADY THAT HAD PREVIOUSLY BENT.

  Patient problems: No Information

  MAUDE report 8615073 ↗
• MalfunctionFeb 27, 2019Dull, Blunt; Dull, Blunt

  SEEMS TO DRAG WHEN IT GOES IN. HE DESCRIBED IT AS 'CATCHING AND HANGING UP' AS IT GOES IN.

  Patient problems: No Information

  MAUDE report 8373449 ↗
• MalfunctionFeb 26, 2019Dull, Blunt; Dull, Blunt

  PATIENT COMPLAINED THAT THIS BRAND DOESN'T WORK AS WELL AS OTHER BRANDS - DOESN'T GO INTO HIS SKIN AS WELL AND THE NEEDLE SEEMS SHORTER THAN OTHER.

  Patient problems: No Information

  MAUDE report 8370106 ↗
• MalfunctionFeb 21, 2019Material Twisted/Bent; Material Twisted/Bent

  PATIENT REPORTED EXPERIENCING ISSUES WITH PEN NEEDLES BENDING WITH BOTH THE 8MM AND 5MM PEN NEEDLES FROM THIS MANUFACTURER.

  Patient problems: No Information

  MAUDE report 8357008 ↗
• MalfunctionFeb 11, 2019Dull, Blunt; Dull, Blunt

  HUSBAND CALLING ON BEHALF OF WIFE. PEN NEEDLES DO NOT EASILY GO INTO SKIN. PEN NEEDLES ARE NOT REUSED.

  Patient problems: No Information

  MAUDE report 8325079 ↗
• MalfunctionFeb 11, 2019Dull, Blunt; Dull, Blunt

  PATIENT COMPLAINED THAT ALL THE BOXES OF THE PRODUCT WERE DULL.

  Patient problems: No Information

  MAUDE report 8325038 ↗
• MalfunctionFeb 11, 2019Dull, Blunt; Dull, Blunt

  PATIENT COMPLAINED THAT ALL THE BOXES OF THE PRODUCT WERE DULL.

  Patient problems: No Information

  MAUDE report 8324967 ↗
• MalfunctionDec 5, 2018Dull, Blunt; Dull, Blunt

  THE PEN NEEDLES ARE NOT GOING IN SMOOTHLY AND ARE VERY PAINFUL. THE PEN NEEDLES PRESSING INTO SKIN WITHOUT PUNCTURING, REQUIRING FORCE TO PUNCTURE. ONCE INJECTION IS GIVEN, AND NEEDLE IS REMOVED, PATIENT COMPLAINS OF BLOOD.

  Patient problems: No Code Available

  MAUDE report 8132310 ↗
• MalfunctionNov 19, 2018Obstruction of Flow; Obstruction of Flow

  PATIENTS ARE PRIMING MULTIPLE TIMES BEFORE INSULIN WILL COME THROUGH.

  Patient problems: No Information

  MAUDE report 8083731 ↗
• MalfunctionNov 19, 2018Dull, Blunt; Dull, Blunt

  THE PEN NEEDLES ARE NOT GOING IN SMOOTHLY AND ARE VERY PAINFUL. THE PEN NEEDLES PRESSING INTO SKIN WITHOUT PUNCTURING, REQUIRING FORCE TO PUNCTURE. ONCE INJECTION IS GIVEN, AND NEEDLE IS REMOVED, PATIENT COMPLAINS OF BLOOD.

  Patient problems: No Code Available

  MAUDE report 8083682 ↗
• MalfunctionNov 16, 2018Dull, Blunt; Dull, Blunt

  PATIENT DESCRIBES PEN NEEDLES AS DULL. SEVERAL CAUSE DIFFICULTY TO INJECT. THEY WILL NOT PUNCTURE THE SKIN EASILY AND AN EXTRAORDINARY AMOUNT OF FORCE HAS TO BE APPLIED.

  Patient problems: No Information

  MAUDE report 8077161 ↗
• MalfunctionNov 13, 2018Dull, Blunt; Dull, Blunt

  PATIENT IS COMPLAINS THE NEEDLES ARE NOT SHARP ENOUGH. PATIENT HAS TO FORCE THEM THROUGH THE SKIN.

  Patient problems: No Information

  MAUDE report 8063430 ↗
• MalfunctionOct 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE INSULIN IS LEAKING OUT OF THE PEN NEEDLES CAP WHEN INJECTING.

  Patient problems: No Information

  MAUDE report 7942205 ↗
• MalfunctionOct 4, 2018Dull, Blunt; Dull, Blunt

  PATIENT CALLED SAYING THAT THE PEN NEEDLES WERE DULL. HE HAS TO FORCE THE PEN NEEDLE INTO HIS SKIN.

  Patient problems: No Information

  MAUDE report 7933295 ↗
• MalfunctionOct 4, 2018Dull, Blunt; Dull, Blunt

  PATIENT CALLED COMPLAINING THAT THE PEN NEEDLES WON'T FULLY GO INTO THE SKIN, THEY ARE STOPPING. THE PEN NEEDLES DOESN'T FEEL SMOOTH GOING IN.

  Patient problems: No Information

  MAUDE report 7933145 ↗
• MalfunctionOct 4, 2018Dull, Blunt; Dull, Blunt

  PATIENT HAS HAD DIFFICULTY INJECTING WITH ALL 3 BOXES HE HAS RECEIVED. HE PUSHES HARD TO INJECT AND THEY DO NOT PUNCTURE THE SKIN EASILY.

  Patient problems: No Information

  MAUDE report 7933064 ↗
• MalfunctionSep 21, 2018Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent

  USER CALL TO LET US KNOW HE IS HAVING ISSUES WITH THE NEEDLES BENDING AND THEY ARE NOT SHARP.

  Patient problems: No Information

  MAUDE report 7897445 ↗
• MalfunctionSep 21, 2018Infusion or Flow Problem; Infusion or Flow Problem

  THE 60-65 UNITS DISPENSED AT A TIME. SOME ARE VERY PAINFUL, SOME NO MEDICINE WILL DISPENSE.

  Patient problems: No Information

  MAUDE report 7897015 ↗
• MalfunctionMar 26, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  MR.(B)(6) IS A VETERAN AND GETS HIS SUPPLIES FROM THE VA. HE WAS SWITCHED FROM EASYTOUCH TO DROPLET, SAME SIZE. HE STARTED USING DROPLET AND STARTED HAVING TROUBLE DISPENSING THE FULL DOSE. HE HAS BEEN A DIABETIC FOR THE LAST 7 YEARS. HE SLIGHTLY PINCHES UP AND DISPENSES THE PEN. IT STOPS WHEN HE HAS ABOUT 4 UNITS LEFT. WITH THE ISSUES, MR. (B)(6) HAD HIS WIFE, A NURSE, TRY TO INJECT HIM AND SHE HAD THE SAME ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7368936 ↗